GUIDELINE OF

THE MALAYSIAN MEDICAL COUNCIL

MMC Guideline 003/2006

ASSISTED REPRODUCTION

Malaysian Medical Council

 PRELUDE

This Guideline complements, and should be read in

conjunction with the Code of Professional Conduct of the
Malaysian Medical Council (MMC).

In this Guideline, the words “doctor”, “Physician”,

“medical practitioner” and “practitioner” are used
interchangeably, and refer to any person registered as a
medical practitioner under the Medical Act 1971. The words
“hospital” and “healthcare Facility and service” are used
interchangeably and refer to any premises in which members
of the public receive healthcare services. Words denoting
one gender shall include the other gender. Words denoting a
singular number shall include the plural and vice versa.

Adopted by the Malaysian Medical Council on 14 November 2006

 FOREWORD

The Malaysian Medical Council, with the objective of ensuring that

registered medical practitioners are fully aware of the codes of professional
medical practice, issues directives and guidelines from time to time. The
purpose of these codes, guidelines and directives is to safeguard the
patient and members of the public, to ensure propriety in professional
practice and to prevent abuse of professional privileges.

The Guidelines are designed to complement, and should be read in

conjunction with, the Medical Act and Regulations, Code of Professional
Conduct of the Malaysian Medical Council and other Guidelines issued by
the Council or any related organisation, as well as any statute or statutory
provisions in force and all related statutory instruments or orders made
pursuant thereto.

This Guideline on Assisted Reproduction has been prepared

with careful attention to details, cognisant of the current international
stand on the subject. The Draft has been reviewed numerous times by
the Malaysian Medical Council and includes valuable response from
individuals, organisations and professional bodies in the country, before
formal adoption by the Council.

The Guideline is available in the printed form as well as in the MMC

website. Registered medical practitioners are advised to familiarise
themselves with the contents, as they will serve as documents to refer
to or to seek clarifications from, when practitioners need guidance on
matters of professional ethics, codes of professional conduct and medical
practice in general.

Tan Sri Datuk Dr. Hj. Mohamed Ismail Merican

MBBS(Mal), MRCP(UK), FRCP(London)(Edinburgh)(Glasgow),
FAMM, FACP(Hon), FRACP(Hon)
President
Malaysian Medical Council

January 2007

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CONTENTS PAGE

INTRODUCTION 5
1. DEFINITION 6
2. PRINCIPLES 8
3. PRINCIPLES FOR QUALITY OF CARE 9
4. CONSENT 10
5. OOCYTE/EMBRYO TRANSFER 11
6. BLASTOCYST TRANSFER 11
7. ASSISTED HATCHING 11
8. EGG DONATION/EMBRYO DONATION/SPERM
DONATION 12
9. SEX SELECTION 12
10. SELECTIVE FETAL REDUCTION 12
11. STORAGE AND DISPOSAL OF GAMETES AND
EMBRYOS 13
12. SURROGACY 13
13. SPERM FREEZING/SPERM BANKING 14
14. PRE-IMPLANTATION GENETIC DIAGNOSIS (PGD): 14
15. PROHIBITED / UNACCEPTABLE PRACTICES 15
FURTHER READING 17

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ASSISTED REPRODUCTION

INTRODUCTION

Assisted reproductive technology (ART) includes a range

of methods used to treat human sub-fertility, including in vitro
fertilization (IVF), embryo transfer (ET), gamete intra-fallopian
transfer (GIFT), and all manipulative procedures involving gametes
and embryos as well as treatment modalities to induce ovulation or
spermatogenesis when used in conjunction with the above methods.

The technology has been developed out of concern for individuals

and couples who are unable to have children when they desire them.
The very broad range of such desires inevitably raises numerous
ethical dilemmas.

Reproductive cloning is not allowed and commercial trading in

gametes, semen or embryos is prohibited under this Guideline.

Explanations of the various treatment modalities used in ART and

the ethical viewpoints regarding each modality are also addressed in
this Guideline.

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1. DEFINITION
Assisted reproductive technology (ART): includes a range of
methods used to circumvent human sub-fertility, including in vitro
fertilization (IVF), embryo transfer (ET), gamete intra-fallopian transfer
(GIFT), all manipulative procedures involving gametes and embryos and
treatment modalities to induce ovulation or spermatogenesis when used
in conjunction with the above methods.

“The reproductive rights rest on the recognition of the basic

right of all couples and individuals to decide freely and responsibly
the number, spacing and timing of their children and to have the
information and means to do so, and the right to attain the highest
standard of sexual and reproductive health”1

These concepts include concern for individuals and couples who are
unable to have
children when they desire them. However, the above statement has
also led to some controversial issue. For examples, a 60 year old woman
may request to have assisted reproduction in order to achieve a pregnancy.
A lesbian couple may want to have a child. Although these rights may be
viewed differently in different societies and communities, it is important
for the medical community to consider these issues in the context of
individual rights, societal concerns, the norms of the community and the
legal framework of the country.

Impaired fertility or sub-fertility may be due to a relative or absolute

inability to conceive, or to repeated pregnancy wastage. It affects both
men and women in approximately equal proportions, causing considerable
personal suffering and disruption of family life.

1. International Conference on Population and Development (ICPD) Cairo

1994)

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The best strategy of dealing with sub-fertility is its prevention.

Although some cases of impaired fertility can be corrected by simple
measures, others require complicated diagnostic procedures and
treatment.

An empathetic approach to individuals and couples who have sub-

fertility problems is required. This includes an appreciation of cultural and
social customs, the individual’s perception of sexuality, an understanding
of the reproductive function and awareness of the aetiology and prevalence
of sub-fertility in the community.

Indeed sub-fertility is now accepted as a condition of poor health and

there are tremendous social and mental effects on a couple that suffer
from sub-fertility.

The development of medically assisted conception to help couples

with sub-fertility has brought new social, legal and ethical issues related
to the management of sub-fertility. Medical practitioners should be fully
cognizant of these issues whenever they are in a position to refer patients
for treatment or whenever they themselves establish a centre for such
activities. These issues involve:

• Respect for the dignity and integrity of the human being.

• Protection of human genetic material so that it is not misused or

used inappropriately without the donors consent.

• The need for quality of care.

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2. PRINCIPLES

In drawing these recommendations, the following principles have

been used as a guide:

• The respect that is due to human life at all stages in its

developments.

• The rights of people who are or may be sub-fertile and the proper
consideration of their request for treatment.

• A concern for the welfare of children, which cannot always

be adequately protected by concern for the interests of adults
involved.

• Recognition of the benefits, both to individuals and to society

which can flow from the responsible pursuit of medical and
scientific knowledge.

• The sanctity of marriage and the importance of marriage prior to

having children is a widely held belief by society in Malaysia. The
difficulty of forcing potential patients to prove their marital status
and maintaining constant checks on the same must be realized
as a practical difficulty for medical practitioners. Be that as it
may, in this country, assisted reproduction techniques must only
be offered to married couples.

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3. PRINCIPLES FOR QUALITY OF CARE

The practitioner should have an effective system for monitoring

and assessing laboratory and clinical practice to ensure that both the
procedures and outcomes are analysed and can be shown to be satisfactory
on independent assessment.

All persons undergoing ART should be adequately tested for

transmittable diseases before procedures are performed on them. Detailed
records must be maintained and be easily retrievable.

The practitioner must maintain accurate record keeping and labelling

in respect of gametes and embryos, and he should ensure that proper
standards are maintained in storage and handling of gametes and
embryos.

There should be an effective monitoring system to ensure high

standards of security wherever gametes and embryos are handled and
stored.

Records should enable authorized staff to trace what happens to an

individual embryo, oocyte or sperm sample from the date of collection.

Centres are responsible for ensuring that standards of quality and

security of genetic material are maintained, wherever the material happens
to be on the premises. This includes material being transferred from
the laboratory for treatment or preparation for treatment. If gametes or
embryos are transferred from one site to another, adequate arrangements
should also be made to protect their quality and security.

Controversies on the use of stored embryos have raised legal disputes,

particularly when the couple involved have since separated, divorced or
one member has deceased or with disagreement by the next of kin. It is

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therefore important that information on such matters should be included

when taking informed documented consent at the time of initial in-vitro
fertilization.

4. CONSENT

The patients generally have the right to give or withhold consent

to examination and treatment. No ART treatment should be given to
any couple without their written consent to that particular treatment
which must be clearly explained to them, including success rates and
complications.

In the course of the discussion, the following aspects must also be

brought up, considered and, where appropriate, consent obtained.

Consent must be obtained from couples for the use of genetic material
for treatment as well as possibly for research; the latter, however, is still
not permitted in Malaysia.

The decision and consent whether couples who have had successful
assisted reproduction would like either disposal or further storage of
genetic material should also be obtained.

While couples have the right to determine the period of storage of

the genetic material, they must be made aware of the period of maximum
statutory period of five (5) years, which may be extended to ten (10)
years if approved by the relevant authority, at the present this being the
Ministry of Health.

The couple must also agree that in the event of them getting separated,
divorced or one of them becoming deceased, one or the other (next of kin
in the case of the deceased) cannot use the stored gametes. The gametes
will then be destroyed.

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5. OOCYTE/EMBRYO TRANSFER

Gametes or embryos which have been exposed to a material risk of

contamination, which might cause harm to recipients or to any resulting
children, should not be used for treatment.

The practitioner and the treated couple should agree upon the number
of embryos transferred, informed consent documents completed and the
information recorded in the clinical record.

Multiple gestation is an unintended result of assisted reproduction

techniques. Multiple gestation leads to an increased risk of complications
in both the fetuses and mother. It would be unethical for the individual
practitioner not to generate his or her own data regarding patient
characteristics, outcomes and number of embryos transferred in order to
minimize these complications.

6. BLASTOCYST TRANSFER

In this procedure, the embryos are allowed to grow beyond the

typical 2-3 days of culture and are allowed to develop to the blastocyst
stage before they are transferred to the womb. A higher pregnancy rate is
thought to result. There are no ethical objections to this practice as it uses
the natural progression of embryo growth.

7. ASSISTED HATCHING

This is a procedure to help in zona pellucida thinning and thus in

implantation. This procedure does not alter the progression of embryo
growth and therefore there are no ethical objections to this procedure.

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8. EGG DONATION/EMBRYO DONATION/SPERM

DONATION

Eggs, embryos and sperms are donated to treat human sub-fertility

in others with the help of assisted reproductive procedures, provided
the unethical and prohibited factors, as listed in Section 15, are adhered
to. The religious and cultural sensitivities of the patient and the medical
practitioner involved in ART procedures should be taken into consideration
before embarking on these procedures.

9. SEX SELECTION

There should be no selection of the sex of embryos for social or

personal reasons. Sex selection is, however, allowed if a particular sex
predisposes to a serious genetic condition e.g. haemophilia, Duchenne
muscular dystrophy, fragile X syndrome, etc.

10. SELECTIVE FETAL REDUCTION

Excessive multi-fetal gestation should be minimized by careful

induction of ovulation and restriction of numbers of embryo transferred.
If despite these measures, more than 3 fetuses are gestated, fetal reduction
may be considered if the prospect of fetal viability is compromised
or if the health or life of the mother is threatened. Patients should be
counselled extensively and informed consent obtained if the procedure
is to be performed.

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11. STORAGE AND DISPOSAL OF GAMETES AND EMBRYOS

A couple undergoing ART should be asked for instruction concerning

the storage and disposal of embryos, as discussed under Consent.

The termination of the development of a human embryo and the

disposal of the remaining materials are sensitive and delicate issues.
The practitioner should take full account of this. Specific instruction
concerning storage and disposal of embryos must be asked of the couple
and informed consent duly obtained.

When an embryo is no longer to be kept for treatment, the practitioner

should decide how it is to be allowed to perish, and what is to happen
to the perished material. The procedure should be sensitively devised
and described, and should be communicated to the people for whom the
embryo was being stored.

Controversies on the use of stored gametes have raised legal disputes,

particularly when the couple involved have since separated, divorced or
one member has deceased (with disagreement by the next of kin). In such
instances, the stored gametes cannot be used independently by either one
of the parties involved. It is therefore important that information on such
matters should be included when taking consent at the time of initial in-
vitro fertilization, as indicated above.

12. SURROGACY

In a surrogate arrangement a women agrees to becomes pregnant and

bear a child for another person/persons and to surrender it at birth. The
above practice is not acceptable to most of the major religions in this
country. Such a surrogate pregnancy can also potentially lead to many
legal dilemmas for the persons involved.

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13. SPERM FREEZING/SPERM BANKING

Cryo-preservation can be used to store sperm. The sperm can be

thawed and used for artificial insemination or in-vitro fertilisation. The
sperm can be stored for future use especially in patients about to undergo
chemotherapy. Sperm can also be retrieved from the epididymis or testes
in those with blockage of the vas deferens. Proper procedures must be
in place for the identification of sperm specimens. The use of donor
semen should be guided primarily by medical needs and the religious
sensitivities of the couple and the medical practitioner involved.

14. PRE-IMPLANTATION GENETIC DIAGNOSIS (PGD):

This procedure involves genetic testing and selection of embryos

produced by in-vitro fertilization (IVF). Once an embryo is created
using IVF techniques, a cell is removed from the embryo after about
three days and tested for specific genetic abnormalities. Usually healthy
embryos will be transferred to the mother’s womb and embryos with the
abnormality will be destroyed.

At present PGD is used mainly for the diagnosis of many diseases

and to determine the sex of the embryo to avoid the transmission of
severe sex-linked disease. Some have attempted to select embryos free of
genetic disease but of the same tissue type as an existing ill child in order
to harvest their umbilical cord blood for transplantation to the affected
sibling.

As there is no worldwide agreement as to when human life begins or

when it acquires moral significance, there is no agreement on the moral
status of an embryo2. Nor is there any agreement as to whether discarding
2. In Islamic interpretation, a foetus is ensouled at 120 days, after which the
conception is considered to possess the qualities of a human being.

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an embryo with a genetic disorder, prior to implantation, is the equivalent

of an abortion.

At present, it is best that PGD be used for only severe and life-
threatening genetic diseases. It would be unethical to analyse and select
the inherited characteristics of embryos (e.g. intelligence, height, hair
and eye colour); any social or psychological characteristics or any other
condition which is not associated with disability or a serious medical
condition.

15. PROHIBITED / UNACCEPTABLE PRACTICES

 No research or experimentation shall be performed using any

human oocyte and/or sperms without the explicit consent of
the donors and approval of the appropriate authority. At the
present time, such research or experimentation is not permitted in
Malaysia.

The following practices are ethically unacceptable and are prohibited

under this Guideline:

 Developing embryos for purpose others than for their use in an

approved ART programme.

 Culturing of an embryo in vitro for more than 14 (fourteen) days.

Human oocyte fertilized with human sperms should not be cultured
in-vitro for more than 14 days (excluding any period of storage
at low temperature). Under no circumstances shall research be
carried out on or using human embryos which are more than 14
days old from the date of conception or the appearance of the
primitive streak, whichever is the earlier, except with the explicit

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approval of the authorizing authority, which is at present the

Ministry of Health..

 Experimentation with the intent to produce two or more genetically

identical individuals, including development of human embryonal
stem cell lines with the aim of producing clones of individuals.

 Under no circumstances should embryo splitting with the intention

of increasing the number of embryos for transfer be allowed.

 Using fetal gametes for fertilisation.

 Mixing of human and animal gametes to produce hybrid embryos.

There shall be no attempt at trans-species fertilisation

 Mixing of gametes or embryos of difference parental origin so as

to confuse the biological parentage of the conceptus.

 Placing an embryo in a body cavity other than the human female

reproductive tract. Under no circumstances should a human
embryo be placed in the uterus of another species for gestation.

 Under no circumstances should the nucleus of a cell of an embryo

be replaced with a nucleus of a cell of another person, another
embryo or a subsequent development of an embryo.

 Under no circumstances should the genetic structure of any cell

be altered while it forms part of an embryo.

 Embryo flushing.

 Commercial trading in gametes, semen or embryos.

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 Pre-implantation diagnosis to create “designer babies” (those with

specific physical, social or specific gender characteristics and not
for the reason of avoiding serious medical illnesses).

 The use in ART treatment programmes of gametes or embryos

harvested from cadavers.

 The use of ART in unmarried couples.

FURTHER READING

1. Ethical guidelines on assisted reproductive technology. National

Health and Medical Research Council, Commonwealth of
Australia, 1996.

2. Consensus on Assisted Reproductive Techniques, Ministry of Health

Malaysia, 1998.

3. Consensus on Assisted Reproductive Techniques. Obstetric &

Gynaecological Society of Malaysia, 1999.

4. Guidelines on number of embryos transferred. American Society for

Reproductive Medicine-A Practice Committee Report January
1998.

5. Canadian Guidelines for Prenatal Diagnosis: Clinical Practice

Guidelines No 105. Journal of Obstetrics and Gynaecology, July
2001.

6. Wertz DC, Fletcher JC, Berg K, Boulyjenkov V Guidelines on ethical

issues in medical genetics and the provision of genetic services.
WHO Hereditary Disease Programme 70. 1995.

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7. Code of Practice: UK Human Fertilisation and Embryology Authority

(HFEA) 7th Ed. 2007.

8. Recommendations on Ethical Aspects of Human Reproduction and

Women’s Health: International Federation of Gynaecology and
Obstetrics (FIGO) 2006.

9. Thornhill AR et al :Best Practice Guidelines for Pre-implantation

Genetics Diagnosis (PGD) and Pre-implantation Genetic
Screening: European Society of Human Reproduction and
Embryology (ESHRE) Consortium. Human Reproduction. Vol20
No.1. 35-48. 2005.

10. Assisted Reproduction Services: Directives for Private Healthcare

Institutions Providing Assisted Reproduction Services: Ministry
of Health Singapore, 2006.

11. Boivin J et al Guidelines for Counselling in Infertility: European

Society of Human Reproduction and Embryology (ESHRE)
Human Reproduction Vol16 No.6. 1301-1304. 2001.

12. Matson P: Screening Standards in ART: Screening of semen donors –

where do we draw the line? Human Reproduction. Vol16 No.10:
2039. 2001.

13. Current Practices and Controversies in Assisted Reproduction: Report

of a meeting in 2001 on “Moral, Ethical and Social Aspects of
Assisted Reproduction” Department of Reproductive Health and
Research, WHO 2002.

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The initial draft of this Guideline on Assisted Reproduction was

prepared by Dr. Ravindran Jegasothy MBBS (Mal), FRCOG (London),
FAMM and revised by Dr. Milton Lum MBBS (Mal), FRCOG (London),
FAMM.

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